Omadacycline: First Global Approval

Drugs. 2018 Dec;78(18):1931-1937. doi: 10.1007/s40265-018-1015-2.

Abstract

Paratek Pharmaceuticals are developing omadacycline (NUZYRA™), a first-in-class orally active aminomethylcycline antibacterial, as a treatment for various bacterial infections. The drug, which is available in intravenous and oral formulations, has a broad spectrum of antibacterial activity and was recently approved in the USA as a treatment for the treatment of community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in adults. This article summarizes the milestones in the development of omadacycline leading to this first global approval for the treatment of CABP and ABSSSI.

Publication types

  • Review

MeSH terms

  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Bacterial Infections / drug therapy*
  • Community-Acquired Infections / drug therapy
  • Drug Approval
  • Humans
  • Skin Diseases, Bacterial / drug therapy
  • Tetracyclines / administration & dosage
  • Tetracyclines / adverse effects
  • Tetracyclines / therapeutic use*
  • United States

Substances

  • Anti-Bacterial Agents
  • Tetracyclines
  • omadacycline